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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical film
Definition To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Product CodeOOD
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
TEPHA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 23 23
2019 17 17
2020 72 72
2021 98 98
2022 430 430
2023 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 331 331
Defective Device 252 252
Patient Device Interaction Problem 219 219
Insufficient Information 96 96
Device Appears to Trigger Rejection 19 19
Adverse Event Without Identified Device or Use Problem 16 16
Migration 12 12
Material Deformation 3 3
Migration or Expulsion of Device 3 3
Tear, Rip or Hole in Device Packaging 2 2
Expiration Date Error 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Expulsion 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 1 1
Thickening of Material 1 1
Device Contamination with Chemical or Other Material 1 1
Contamination 1 1
Material Protrusion/Extrusion 1 1
Torn Material 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 184 184
Pain 146 146
Injury 72 72
Impaired Healing 61 61
Unspecified Infection 51 51
Seroma 51 51
Wound Dehiscence 43 43
Disability 33 33
Necrosis 30 30
Hernia 29 29
Erythema 26 26
Hematoma 25 25
Breast Discomfort/Pain 22 22
Bacterial Infection 21 21
Capsular Contracture 18 18
Fluid Discharge 18 18
Unspecified Reproductive System or Breast Problem 17 17
Swelling/ Edema 15 15
No Clinical Signs, Symptoms or Conditions 15 15
Physical Asymmetry 12 12
Post Operative Wound Infection 9 9
Abdominal Pain 8 8
Cellulitis 7 7
Breast Cancer 6 6
Ptosis 6 6
Cancer 5 5
Purulent Discharge 5 5
Hypersensitivity/Allergic reaction 5 5
Erosion 5 5
Abscess 5 5
Rash 5 5
Scar Tissue 4 4
Nerve Damage 4 4
Itching Sensation 4 4
Fistula 4 4
Unspecified Tissue Injury 4 4
Obstruction/Occlusion 4 4
Skin Disorders 3 3
Death 3 3
Inflammation 3 3
Sepsis 3 3
Vomiting 3 3
Nausea 2 2
Adhesion(s) 2 2
Cyanosis 2 2
Skin Inflammation/ Irritation 2 2
Blister 2 2
Drug Resistant Bacterial Infection 2 2
Breast Mass 2 2
Reaction 2 2
Urticaria 2 2
Discomfort 1 1
Urinary Frequency 1 1
Fasciitis 1 1
Deformity/ Disfigurement 1 1
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Implant Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Contact Dermatitis 1 1
Nodule 1 1
Neuralgia 1 1
Muscle/Tendon Damage 1 1
Autoimmune Reaction 1 1
Diarrhea 1 1
Micturition Urgency 1 1
Hypoxia 1 1
Neuropathy 1 1
Pocket Erosion 1 1
Loss of Range of Motion 1 1
Burning Sensation 1 1
No Consequences Or Impact To Patient 1 1
Swelling 1 1
Raynauds Phenomenon 1 1

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